MONOLISA Anti-HBs EIA

Excellent Percent Agreement with Other Anti-HBs FDA Approved Assays

The percent agreement between the MONOLISA™ Anti-HBs EIA and the reference anti-HBs assays was evaluated for each specimen classification.

Percent Agreement: MONOLISA Anti-HBs EIA versus Reference Anti-HBs EIA

The positive percent agreement with the reference method is 94.3% (567/601) with a 95% confidence interval of 92.2–95.9%. The negative percent agreement with the reference method is 93.5% (779/833) with a 95% confidence interval of 91.6–95.0%.
The 18 specimens that were indeterminate by both assays were not included in the percent agreement calculations.

MONOLISA™ Anti-HBs EIA

Excellent Correlation with the Official WHO Reference Standard Panel

Dilutions of the WHO First International Reference Preparation for Antibody to HBsAg (1977) were run in the Bio-Rad MONOLISA Anti-HBs quantitative assay. A linear regression of the mean anti-HBs EIA result versus the calculated concentration of each WHO dilution was used to determine the anti-HBs concentration.

Quantification and Wide Calibration Range: MONOLISA Anti-HBs Calibrator Kit

MONOLISA Anti-HBs Calibrator Kit allows measurement of a wide range of values in a calibration curve from 0 to 1000 mIU/mL without the need for dilution of high-titer samples.

Anti-HBs EIA: WHO Standard

MONOLISA™ Anti-HBs EIA Testing Procedure

Test Format			Color of well BEFORE addition		Color of well AFTER addition
		Microplate coated with human HB antigen, subtypes ad and ay
		75 μL of control or sample and 25 μL of Specimen Diluent Incubate for 1 hour at 37°C
Wash
		100 μL of Working Conjugate Solution Incubate for 1 hour at 37°C
Wash
		100 μL of Working TMB Solution Incubate for 30 minutes in the dark at room temperature (18–30°C)
		100 μL of Stopping Solution Cutoff = Mean OD of 10 mIU/mL Cutoff Calibrator
READ at dual wavelength 450/615–630 nm and 405/615–630 nm
Human HBs antigen   HBs antigen labeled with peroxidase   Anti-HBs Ab from sample   * Reactive samples after 30 minute incubation

Serology Profiles

Hepatitis B: Example of Acute Hepatitis

Comprehensive Product Line for Hepatitis Testing

Fast incubation time: 2.5 hours		Standardized procedure for all Bio-Rad assays		Microplate strip identification
Common reagents for all Bio-Rad kits		Color-coded reagent and kit labels		Color changes during protocol steps
Manual and automated use		Barcoded reagents		Controls with color-coded caps